Advice

NICE has developed a medtech innovation briefing (MIB) on Axxent electronic brachytherapy system for early stage breast cancer.

The technology described in this briefing is the Axxent electronic brachytherapy (eBx) system. It delivers single‑dose intraoperative radiotherapy (SD‑IORT) during breast-conserving surgery for people with early‑stage breast cancer.

The innovative aspects are that it incorporates a miniaturised 50 kV X-ray source in which no radioisotopes are needed, and is provided to any suitable hospital as a managed service using a mobile platform.

The intended place in therapy for the Axxent eBx system is in the current NHS pathway for patients offered SD‑IORT in place of external beam radiotherapy (EBRT), which is usually given in daily radiotherapy sessions for 3 weeks.

The key points from the evidence summarised in this briefing are from 6 non-comparative studies including 452 patients. There is a lack of robust evidence evaluating the Axxent eBx system for early‑stage breast cancer. In general, SD‑IORT using Axxent eBx was well tolerated with a low rate of adverse events and good cosmetic outcomes.

Key uncertainties around the evidence are that the available studies include patients for whom the technology is not recommended by the manufacturer, and there is a lack of long-term follow-up evidence.

The cost per patient of the Axxent eBx managed service is £3,750 (excluding VAT). There is no capital equipment purchase, maintenance cost or servicing charge. In comparison, external beam radiotherapy costs £2,821 per patient (15 fractions) in addition to the initial purchase and maintenance costs of a linear accelerator.

MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.